MDMA-Assisted Internal Family Systems Therapy for Eating Disorders: An Observational Pilot Study

Abstract

The purpose of this retrospective, naturalistic observational cohort study is to investigate the real-world safety and preliminary effectiveness of MDMA-assisted Internal Family Systems (IFS) therapy in adults with self-reported, clinically diagnosed eating disorders (EDs). The primary objective is to assess safety and tolerability by describing the type, severity, and frequency of self-reported adverse events (AEs) at 1-week post-treatment. The secondary objective is to evaluate potential effectiveness by estimating within-person change in self-reported ED symptoms from baseline to 1-week post-treatment and at 3-months follow-up. Exploratory outcomes include within-person changes in self-reported anxiety, depression, PTSD symptoms, and suicidality. All findings will be considered preliminary and non-causal, intended to support signal detection and inform subsequent, hypothesis-driven clinical trials.

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